Method of use of hybrid infra-red laser and pulsed electromagnetic medical apparatus

ABSTRACT

Apparatus and methods for simultaneously providing an infra-red laser beam and a concentrated uni-polar, pulsed electromagnetic field to a region of interest in the body of a patient are disclosed. The apparatus produces the infrared laser beam from a laser diode and the pulsed electromagnetic field from an electrically conductive coil. The infra-red laser beam and the pulsed electromagnetic field are produced concurrently along a common axis. A focusing magnet is provided to concentrate the lines of flux so that they extend along the laser beam. The apparatus includes a body of Mu-metal shielding surrounding the components of the apparatus except for one pole of the coil from which the lines of flux of the electromagnetic field extend to further concentrate the field and render it effectively uni-polar.

CROSS-REFERENCE TO RELATED APPLICATIONS

This divisional application claims priority under 35 U.S.C. §121 ofbypass continuation application Ser. No. 14/611,726 filed on Feb. 2,2015 which claims priority under 35 U.S.C. §120 of international patentapplication PCT/IB2014/001849 filed on Sep. 12, 2014 and all of whoseentire disclosures are incorporated by reference herein.

FIELD OF THE INVENTION

This invention relates generally to medical devices and methods of useand more particularly to apparatus making use of an Infra-red Laser anda Pulsed Electromagnetic Field and methods of use for treating variousmedical conditions.

BACKGROUND OF THE INVENTION

The therapeutic application of Pulsed Electromagnetic Field (“PEMF”)therapy has been accepted by the Food and Drug Administration for use inhumans and has become an accepted modality in treating various medicalconditions. Typically PEMF therapy is achieved by means of apparatusmaking use of at least one inductive coil producing a pulsatingelectromagnetic field. The coil(s) is/are energized by applying apredetermined electrical current to the coil(s) in order to produce adesirable magnetic field with specified field characteristics.

Infra-red radiation also has many benefits to the human body and thereare many clinics that use infra-red for treatment of aging process andits related complications. The problem is that infra-red cannotpenetrate deep tissues. Historically its main use for therapeuticpurposes has been directed to skin and the very near subcutaneoustissues. However, the introduction of pulsed infra-red laser that canpenetrate deeper tissues has enabled the treatment of other conditionsinvolving deeper tissue penetration.

While each of those modalities offers beneficial, e.g., therapeutic,effects, it is believed that their combination will offer even agreater, i.e., synergistic, effect. Accordingly, the subject inventionis directed to apparatus and methods for providing infra-red radiationtherapy concurrently with PEMF therapy.

SUMMARY OF THE INVENTION

In accordance with one aspect of the invention there is providedapparatus for applying infra-red laser radiation and pulsedelectromagnetic energy to an anatomic region of interest located withinthe body of a patient. The apparatus basically comprises a housing, aninfra-red laser, a coil of electrically conductive material, a focusingmagnet, a body of Mu-metal shielding, an electrical power supply, and acomputer processor. The infra-red laser is located within the housingand is arranged for providing a collimated infra-red laser beam along anaxis. The coil is disposed within the housing surrounding the laser beamand is arranged when electrically energized to create a pulsedelectromagnetic field extending along the axis of the laser beam. Oneend portion of the coil establishes a first electromagnetic pole andanother end portion of the coil establishes a second electromagneticpole. The second electromagnetic pole is of opposite polarity to thefirst electromagnetic pole. The axis of the laser beam extends throughthe first and second poles, with lines of flux of the magnetic fieldextending outward from the first pole generally parallel to thelongitudinal axis. The focusing magnet is disposed within the housingadjacent the first pole of the coil to encircle the laser beam. Thefocusing magnet includes a first pole of a first polarity and a secondpole of a second polarity. The first pole of the focusing magnet islocated radially inward of a second pole of the focusing magnet and isthe same polarity as the first pole of the coil to thereby concentratethe lines of flux of the electromagnetic field along the axis of thelaser beam. The body of Mu-metal shielding surrounds the coil and thefocusing magnet except for the first pole of the focusing magnet so thatthe first pole of the focusing magnet is exposed and from which thelines of flux of the magnetic field and the laser beam emanate.

Other aspects of this invention entail various methods of treatingmedical conditions of a patient by applying the infra-red laser beam andthe pulsed electromagnetic field to a region of interest in the body ofthat patient. Those methods basically comprise providing apparatussimilar to that described above, disposing the apparatus adjacent theregion of interest of the patient and operating the apparatus to producethe infra-red laser beam and the pulsed electromagnetic field and directboth concurrently to a region of interest in the body of that patient.

DESCRIPTION OF THE DRAWING

FIG. 1 is a partial cross-sectional view of one exemplary embodiment ofa hybrid apparatus for providing both Infra-red laser radiation therapyand PEMF therapy constructed in accordance with this invention; and

FIG. 2 is a sectional view of the apparatus of FIG. 1 taken along line2-2 thereof.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the various figures of the drawing wherein likereference characters refer to like parts, there is shown in FIG. 1 at 20apparatus for concurrently producing an infra-red laser beam and acollimated (or otherwise concentrated) uni-polar pulsed electromagneticfield (PEMF) to the body of a patient to provide therapy to an anatomicregion of interest therein. It is believed that the combination of thosetwo modalities applied concurrently will provide a synergistic effect.In particular, infra-red laser therapy and PEMF therapy each have a goodresponse in the treatment of the same groups of diseases. The mechanismof action of both infra-red laser therapy and PEMF therapy is believedto be through mitochondrial and regenerative medicine pathways. Themitochondrial mechanism is achieved via application of external energythat can be utilized by the tissues to compensate for energy deficitproduced from the mitochondria. The regenerative medicine mechanism isthat both infra-red laser and PEMF can activate stem cells. Moreover, anexternally applied PEMF can control the orientation of the hydrogenatoms of water of the patient's tissues in the region of interestthereby concentrating the infra-red energy applied to those tissues bythe laser beam. Thus, it is believed that the combination of aninfra-red laser beam along with a PEMF, particularly a unipolar PEMF,has a synergistic effect.

Turning now to FIG. 1, it can be seen that the apparatus 20 basicallycomprises a housing 22, an infra-red laser diode 24, a coil 26 ofelectrically conductive material, a focusing magnet 28, a body ofMu-metal shielding 30, an electrical power supply/controller 32, and acomputer processor 34. All of the foregoing components except for theelectrical power supply/controller 32 and the computer processor 34 arelocated within the housing 22. The electrical power supply/controller 32and the computer processor 34 are located in a separate housing 36 andare electrically connected to the infra-red laser diode 24 and the coil26 via an electrical cable 38. Power for the electrical powersupply/controller 32 and the computer processor 34 is provided via aconventional plug (not shown) adapted to be connected to a 110 volt walloutlet (not shown). The power supply/controller 32 provides electricalpower to the laser diode 24 to cause it to emit an infra-red laser beam40, whose frequency and intensity is established by the computerprocessor 34. The power supply/controller 32 also provides electricalpower to the coil 22 to cause it to produce a pulsed electromagneticfield (PEMF) 42.

It should be pointed out at this juncture that, if desired, all of thecomponents of the apparatus 20 can be located within the housing 22instead of being in separate housings. In any case, the housing 22 ispreferably sufficiently compact so that it can be hand-held by a user todirect the infra-red laser beam 40 and the PEMF 42 produced by itscomponents to a region of interest in the body of a patient for sometherapeutic or other beneficial purpose. The housing 22 can be formed ofany suitable material, e.g., plastic.

The infra-red laser diode 24 can be of any suitable construction, e.g.,like those conventionally used in the prior art for effecting infra-redradiation therapy, and is mounted in the housing 22 so that theinfra-red laser beam 40 produced by it extends along a longitudinal axis44 and projects out of one end of the housing 22 as shown in FIG. 1.

In accordance with one exemplary embodiment of this invention theapparatus is arranged to produce an infra-red laser beam which is pulsedat a frequency in the range of 50,000 Hz to 100,000 Hz, with the powerof the laser beam being in the range of 25-50 watts.

The coil 26 basically comprises a helical member made up of one orplural electrical conductors wound in a helix. The coil is locatedwithin the housing adjacent the laser diode 24 so that its centrallongitudinal axis is coincident with the axis 44 of the laser beam 40produced by the diode. The conductor(s) of the coil is/are coupled tothe electrical power supply/controller 32 so that when energized thecoil produces the electromagnetic field 42 having flux lines centeredabout and extending along the longitudinal axis 44. In the exemplaryembodiment shown the South (S) pole of the coil 26 is located adjacentthe laser diode 24 and the North (N) pole of the coil is at the oppositeend, e.g., adjacent the end of the housing from which the laser beamemanates. If desired, the poles of the coil can be reversed, providingthat the poles of the focusing magnet are oriented appropriately, aswill be discussed later. In any case, the coil surrounds the infra-redbeam so that the passage of the beam is unobstructed through thehousing.

In the exemplary embodiment shown in the drawing the focusing magnet 28is a permanent magnet which is ring or circular shaped. The North (N)and South (S) poles of the magnet are oriented radially with respect toeach other. In the exemplary embodiment the North pole is located at theinnermost portion of the magnet, while the South pole is at theoutermost (peripheral) portion of the magnet. The magnet 28 produces avery strong magnetic field which serves to focus or collimate the linesof flux of the field emanating from the North pole of the coil 26. Inparticular, the lines of flux from the field produced at the North poleof the focusing magnet 28 repel the lines of flux produced by the Northpole of the coil (which would tend to splay or spread out), thus causingthe lines of flux of the field 42 to become more concentrated orcollimated. This concentration helps the electromagnetic field 42 go fora longer distance before spreading out further to enable deeper tissuepenetration. The combination of deeper tissue penetration with highconcentration means more efficient energy delivery to the tissues at theregion of interest.

In addition to the shaping of the field 42 provided by the focussingmagnet 28, the PEMF field 42 is also shaped and collimated by the bodyof Mu-metal shielding 30. In particular, the body of Mu-metal 30 islocated within the housing 22 and has a circular bore 46 in which thelaser diode 24 and the coil 26 are located. A portion 48 of the bore 46opposite the position of the diode is of enlarged internal diameter andserves to hold the ring shaped focussing magnet 28 therein. The endportion of the Mu-metal body includes a radially extending wall 50covering the end of the focussing magnet, and has an opening 52 throughwhich the laser beam 40 and the lines of flux of the PEMF 42 emanate fordirection to the region of interest in the patient to be treated. Withthe Mu-metal body 30 shaped and located as described above, the lines offlux of the field 42 produced by the coil are concentrated or collimatedby the surrounding Mu-metal so that those lines of flux extend generallyparallel to the central longitudinal axis 40 for a substantial distancebeyond the end of the housing as shown in FIG. 1 to apply the pulsedmagnetic energy to the region of interest.

It should be noted that while the lines of flux produced by the coil 26do, in fact, curve back to the coil's South pole, they are shaped andconfined by the Mu-metal shield so that their effect on the region ofinterest is minimal, if any. Thus, the inclusion of the Mu-metal shield30 results in the production of a magnetic field emanating from theapparatus 20 which is effectively uni-polar.

As mentioned above, in the exemplary embodiment shown in FIG. 1, theuni-polar magnetic field is of North polarity, i.e., it consists of theconcentrated lines of flux from the North pole of the coil, since formany therapies it is desired to utilize the North pole as the treatingmodality, inasmuch as the North pole seems to provide betterphysiological effects on human cells. Thus, in the exemplary embodimentthe apparatus 20 is arranged to have the North poles of the coil 26exposed, with the South pole of the coil being shielded by the Mu metalbody 30. For other applications, the South pole of the apparatus 20 maybe utilized. In such a case the South pole of the coil will be exposed,with the Mu metal body 30 surrounding the North pole of the coil and thepoles of the focusing magnet 28 will be reversed, i.e., the North poleof the focusing magnet will be on the outer periphery of the focusingmagnet.

In accordance with a preferred embodiment of this invention theelectrical energy applied to the coil is pulsed at a frequency in therange of 11 Hz to 30 Hz basis to produce the PEMF 42. To that end, therewill be a “on” time period during each cycle of operation of theapparatus wherein the magnetic flux emanating from the apparatusimpinges the anatomic region of interest in the patient, therebyapplying magnetic energy to that region, and an “off” time period duringeach cycle when no magnetic flux from the coil will reach the anatomicregion of interest. The computer processor 34 is arranged to establishthe “on” and “off” time periods of the duty cycle of operation of theapparatus 20 (i.e., the time that the region of interest is exposed tothe collimated magnetic field). In accordance with a preferred exemplaryembodiment of this invention the ratio of the on-to-off periods of timeis preferably in the range of 50%-70% on and 50%-30% off, at an on-offpulse rate of approximately 11 to 30 per second. The above ranges aremerely exemplary and other duty cycles can be utilized depending uponconditions. The intensity of the PEMF can be whatever is deemedappropriate for the application, e.g., approximately 600 Gauss or less.

Use of the apparatus of this invention, like the exemplary apparatus 20(or any other apparatus constructed in accordance with this invention)for providing various therapies in accordance with this invention willnow be described. For example, the exemplary apparatus 20 of FIG. 1 canbe used for treating a brain disorder or condition. To that end, theapparatus 20 is disposed adjacent the skin of the patient at a desiredposition adjacent the patient's skull and juxtaposed and oriented sothat the portion of the housing 22 from which the infra-red laser andthe unipolar PEMF emanate along axis 44 is directed to region ofinterest in the patient brain to treat the particular pathology. Whenthe apparatus 20 is in the desired position and orientation theapparatus may be activated (turned on). This can be accomplished bypressing an ON/OFF switch or button (not shown) on the apparatus'housing 22 to energize the laser diode 24 and to simultaneously energizethe coil 26. Thus, the infra-red laser beam 40 and the uni-polar PEMF 42will be produced concurrently along axis 44 so that they are directed tothe region of interest in the patient's skull to penetrate through theskin and underlying tissue and bone of the skull to the situs of thepathology.

In closing it should be noted that the particular components and theirarrangements as discussed above and as shown in the drawing are merelyexemplary. Thus, other components can be used in lieu of thosedisclosed. By way of example, and not limitation, the shield 30 may beformed of some material having similar magnetic field modifying effectsas Mu-metal. Moreover, the focussing magnet 28 may be in the form of aplurality of permanent magnets arranged in a ring-like configurationsurrounding the axis of the laser beam, so long as the portion of thosemagnets closest to the end of the coil from which the PEMF emanates isof the same polarity as that end of the coil. Moreover, it is alsocontemplated that the focussing magnet may be an electromagnet insteadof a permanent magnet. Further still, while the apparatus is preferablysufficiently small so that it can be hand-held by a user, it can, ifdesired, be supported by some mount, e.g., an adjustable member. Lastly,while it is preferable that the laser and the electromagnetic field eachbe pulsed, either or both, need not be pulsed for a particularapplication, e.g., treatment of the skin or other closely locatedtissue.

Without further elaboration the foregoing will so fully illustrate ourinvention that others may, by applying current or future knowledge,adopt the same for use under various conditions of service.

We claim:
 1. A method of treating medical condition of a patient byapplying an infra-red laser beam and a pulsed unipolar electromagneticmagnetic field to deep tissue in the body of the patient, the deeptissue being deeper than the skin and subcutaneous tissue, said methodcomprising: a) providing an apparatus having a longitudinal axis, saidapparatus comprising a coil and at least one focusing magnet forproducing a unipolar concentrated pulsed electromagnetic field, saidapparatus also producing an infra-red laser beam; b) disposing saidapparatus outside the body of the patient but adjacent the deep tissuein the body of the patient; and c) operating said apparatus toconcurrently produce said infra-red laser beam along said longitudinalaxis and said unipolar concentrated pulsed electromagnetic field alongsaid longitudinal axis, wherein said infra-red laser beam is pulsed at afrequency in a range of 50,000 Hz to 100,000 Hz, wherein a power of saidlaser beam is in a range from 25 to 50 watts, wherein said pulsedelectromagnetic field is pulsed at a frequency in a range of 11 Hz to 30Hz and wherein an intensity of said pulsed electromagnetic field is 600Gauss; and d) directing said infra-red laser beam and said unipolarconcentrated pulsed electromagnetic field to said deep tissue in thebody of the patient.